ANDA 209684

ACCORD HLTHCARE

FDA Drug Application

Application #209684

Application Sponsors

ANDA 209684

ACCORD HLTHCARE

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	30MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
002	TABLET, EXTENDED RELEASE;ORAL	60MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
003	TABLET, EXTENDED RELEASE;ORAL	120MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209684
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/24\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-24
        )

)